Oxcarbazepine Date of…
Oxcarbazepine Date of publication: 18/10/2023
Amoxicillin/amoxicillin…
Amoxicillin/amoxicillin trihydrate Date of publication: 18/10/2023
Vancomycin hydrochloride Date…
Vancomycin hydrochloride Date of publication: 18/10/2023
Paricalcitol Date of…
Paricalcitol Date of publication: 18/10/2023
Ipratropium bromide Date of…
Ipratropium bromide Date of publication: 18/10/2023
Itopride Date of publication:…
Itopride Date of publication: 18/10/2023
Lamotrigine Date of…
Lamotrigine Date of publication: 18/10/2023
ICH Q9(R1) Quality Risk Management Training Materials now available on the ICH Website
The ICH Secretariat is pleased to announce the publication of Q9(R1) Quality Risk Management Training Materials.
eSubmission Gateway XML delivery file update for Article 18 submissions
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Human submissions (option to choose Article 18 as submission type).
Updated version of the VNeeS specification v3.1 now available
The guideline on eSubmissions for Veterinary products version 3.1 has now been published. It will enter into force on 1 November 2023 (see links under section Current Guidance).